Parenteral solution equipment



1962 F. GOYKE 3,050,061

PARENTERAL SOLUTION EQUIPMENT Filed May 29, 1957 /N VE N TOR ATTORNEYS.

n ates trite This invention relates to parenteral solution equipment andthe use thereof, and more particularly to equipment useful insupplementing bulk parenteral solutions.

The bulk parenteral solutions to which this invention is directed, areusually considered to be solutions in excess of 250 cc. Most usually,these solutions are provided in sizes of 250 cc., 500 cc., and 1000 cc.Depending upon the quantity of the solution and the requirements of thepatient, the administration of these solutions may vary over a periodfrom about one hour to as much as eight hours. The administration isusually achieved by a length of tubing communicated at one end with aparenteral solution bottle mounted mouth-downwardly and at the other endwith a needle inserted under the skin of an intended recipient. Suitableflow-regulating means are associated with the administration set,usually a drip-meter and clamp for the tubing so as to permit dropwiseadministration of the parenteral solution.

Although parenteral solutions are often thought of in terms as a sourceof intravenous feeding, they are by no means limited to providingnutriment. They have been found useful in maintaining the recipientagainst shock, such as attends the loss of blood during surgery. Theyhave been used to maintain the salt level of the blood in thisconnection. They have also been used as carriers for anesthetics andother associated medicines.

The wide use of parenteral solutions permits them to act as carriers fora wide variety of medicines. It is to be appreciated, however, thatbecause of their bulk, a wide variety of parenteral solutions cannot beconveniently stored, even in hospitals of considerable size. Thus, it isnot uncommon for parenteral solutions of a basic nature, such as glucoseor saline, to be supplemented by a particular medicine just prior totheadministration of the bulk parenteral solution. I have noted reportsthat show that in as many as one in every four administrations, thebasic solution has been supplemented by one type of medicine or another.This is particularly the case in the use of certain preparations such asvitamins that are unstable as water solutions.

Because of the increasing frequency with which basic parenteralsolutions are being supplemented, a problem has arisen in theperformance of this supplementation in a quick, efficient, and asepticmanner.

It is a general object of this invention to provide equip ment and theuse thereof that solves the foregoing problem. Another object is toprovide equipment to accomplish supplementation of a bulk parenteralsolution with a minimum of manipulation, whereby aseptic transfer issubstantially achieved. Still another object is to provide a novelmethod of supplementing a bulk parenteral solution. Yet another objectis to provide a method for transferring a supplementing medicament froma separate source to a bulk parenteral solution container only under theinfluence of gravity. A still further object is to provide a method ofsupplementing a bulk parenteral solution in which the supplementalmedication is introduced through the air tube of a bulk parenteralsolution bottle. A still further object is to provide a novel closurestructure for an additive vial which achieves the purposes and objectsset forth above. Other objects and 3,050,061 Patented Aug. 21, 1962advantages of my invention can be seen as this specification proceeds.

This invention will be explained in conjunction with the accompanyingdrawing, in -which FIGURE 1 is a cross-sectional view of a bulkparenteral solution container in communication with an additive vial;and FIG. 2 is an elevational view, partially in section, similar to FIG.1 but showing the structure of FIG. 1 in a different operativecondition.

In the illustration given, the numeral 10 (in both figures) denotesgenerally a parenteral solution container. Container 10 includes a glassbottle 11 provided with an annular groove or recess 12 adjacent thebottom thereof. Mounted on bottle 11 within recess 12 is band 13.Attached to lugs or ears 13a of band 13 is bail 14 (seen only in FIG.2). Bail 14 and band 13 cooperate to provide a convenient means forsuspending bottle 11 in a mouth-downward fashion, such as is shown inFIG. 1, and which is the position employed during dispensing of liquidfrom parenteral solution container 10.

Bottle 11 is provided with a mouth 15 into which is inserted stopper 16.Conventionally, stopper 16 is constructed of a resilient material suchas rubber or rubber substitutes. Stopper 16 is provided with an annularflange portion 17 which overlies the top lip of bottle 11. Stopper 16 ismaintained in place in the neck 15 of bottle 11 by a clamping ring 18which is anchored to an annular bead 11a provided in the external wallof bottle 11. Overlying stopper 16 is a frangible diaphragm 19.Extending through stopper 16 are passages 20 and 21. Mounted withinpassage 20 and extending inwardly of bottle 11, is an air tube 22.

When the solution 23 contained within bottle 11 is intended to bedispensed without supplementation, the connector portion of anadministration set is inserted into passage 21, the act of insertioncausing rupture of diaphragm 19 if it has not already been removed.Suitable puncture of diaphragm 19 is also required in the portionoverlying passage 20. When bottle 11 is disposed in the condition shownin FIG. 1, parenteral solution 23 flows out of passage 21 and the spacevacated by solution 23 is replaced by air entering through passage 20and air tube 22.

The foregoing parenteral solution container structure and operation isconsidered conventional, and is set forth in detail only for the sake ofclearness of understanding of this invention. In this connection, it isto be noted that in some instances integral diaphragms are provided instopper 19 to close passages 20 and 21.

In both FIGURES, the numeral 24 designates generally an additive vialstructure which embodies teachings of this invention. Vial 24, likebottle 11, can be conveniently constructed of glass. Vial 24 is equippedwith a top closure 25 which, in the illustration given, is shown securedto vial 24 in a manner similar to the securement of stopper '16 tobottle 11. In the illustration given, vial stopper 25 is provided withan annular flange 25a which overlies the top lip of vial 24. Stopper 25is maintained in place by a clamping ring 26 which is anchored to vial24 under an annular bead 24a.

Extending through stopper 25 are a pair of passages 27 and 28. Passages27 and 28 are spaced apart a distance approximately the same as theseparation of passages 20 and 21 in stopper 16.

Mounted in passageway 27 is connector fitting 27a. Fitting 27a extendsoutwardly of vial 24 and is shown inserted into passage 21 of stopper 16of parenteral solution container 10.

Mounted in passageway 28 is puncture fitting 29, which is shown insertedinto passage 20 of stopper 16. Preferably, fitting 29 is of a lengthsufficient to extend into air tube 22 when fitting 27a is inserted intopassage 21 and in communication with parenteral solution 23.

Fitting 29 is provided with a tight fitting annular sleeve 30 whichterminates a distance spaced from the end of puncture fitting 29.Optimum operation is achieved when sleeve 30 is constructed of aresilient material such as rubber, in which case it can act as a seal incooperation with stopper 16 or diaphragm 19, as the case may be.

It is believed that a brief description of the use of vial 24 in theenvironment set forth will be helpful in understanding this invention.

Operation When it is desired to supplement a parenteral solution 23 suchas is contained within parenteral solution container with a liquidmedicine, it is only necessary to communicate the suplementalmedicine-containing vial with the parenteral solution container as shownin FIG. 2. In FIG. 2, the mouth of bulk parenteral solution container 10is positioned upwardly. Not shown associated with additive vial 24 is asuitable protector or cap structure for fittings 27a and v29 to protectthem from contamination. When additive vial 24 is coupled orcommunicated to container 10 as shown in FIG. 2, the liquid 31 in vial24 flows downwardly through fitting 29 into air tube 22 and eventuallyinto the body of solution 23. Meanwhile, air moves from container 10upward through fitting 27a into Vial 24 to replace the liquid which isdispensed therefrom under the influence of gravity. During the transferof liquid medicine 31 from vial 24 into container 10, vial 24 andcontainer 10 provide a closed system, i.e., a system in which no contactwith unsterile outside air is permitted. As seen in FIG. 2, fitting 27ais pressed-fitted into passage 21 of stopper 16 so as to effectivelyseal air from entering container 10 through passage 21. The abutment ofsleeve 30 against the top surface of stopper 16 likewise prevents entryof unsterile air into parenteral solution container 10.

When it is desired to supplement parenteral solution 23 with a solidmedicament, the arrangement shown in FIG. 1 is first employed. In FIG.1, as in the arrangement just described with respect to FIG. 2, vial 24and container 10 are communicated by virtue of having fittings 27a and29 inserted into passageways 21 and 20, respectively. The coupled orcommunicated vial 24 and container 10 are disposed in the position shownin FIG. 1, wherein container 10 is uppermost and positioned in amouth-downward condition. When such is the case, solution 23 flows outof container 10 through passage 21 and through fitting 27a into vial 24to come in contact with the solid medica ment container in vial 24. InFIG. 1, particles 32 of solid medicament contained within vial 24 areshown in a state prior to solution or dispersion within solution 23.Meanwhile, air from vial 24 is forced upwardly through fitting 29 intoair tube 22 and therefrom as shown by the arrows in FIG. 1 to replacethe liquid solution withdrawn from container 10. After a short period,all air is forced from vial 24 and any solid medicament therein isdispersed or dissolved in solution 23 entering vial 24. Thereafter,inversion of the coupled vial and bottle to the condition shown in FIG.2 results in flow of liquid 31 from vial 24 as described above, the airentering vial 24- through fitting 27a and being shown in the form ofbubbles 33.

From the foregoing, it is seen that the structure and method of thisinvention permits the supplementation of bulk parenteral solutions witha minimum of manipulation. All that is required is coupling of amedicamentcontaining vial to a parenteral solution bottle. This isachieved by thrusting fittings 27a and 29 into passageways 21 and 20,respectively, when container 10 is positioned mouth-downwardly, as seenin FIG. 1. Flow of liquid out of container 10 is prevented by virtue ofdiaphragm 19 closing passages and 21. Alternatively, it is possible tocouple vial 24 to container 10 when the latter is positioned as shown inFIG. 2, i.e., mouth-up- Ward. This has been found particularlyconvenient when vial 24 contains a solid medicament, since a solidmedicament does not have a tendency to flow out of vial 24.

After insertion of fittings 21 and 20, liquid solution 23 from container10 flows into vial 24, diluting or dissolving the medicament containedin vial 24 and effectively making it possible to transfer all of themedicament into container 10. Thereafter, inversion of the coupledcontainer and vial to the condition shown in FIG. 2 efiectuates transferof the supplemental medication.

While, in the foregoing specification, my invention has been set forthin considerable detail to facilitate understanding thereof, it is to beunderstood that variations therein will be apparent to those skilled inthe art and that no unnecessary limitations are to be inferred from theforegoing detailed description, given, as it is, for purposes ofillustration.

I claim:

1. In combination, a parenteral solution container equipped with aresilient stopper, said stopper having a pair of passages thereinadapted to communicate the interior of said container with the exteriorof said stopper, an air tube mounted in one of said passages andextending only inwardly of said container and to a point adjacent thebottom of said container, a vial containing a supplemental medicamentfor the container solution, a closure secured to said vial, said closurebeing equipped with a pair of spaced apart spouts of equal lengthextending only outwardly of the portion of said closure connected tosaid vial, said spouts having passages extending there through, both ofsaid spouts being of generally circular cross-section and one spoutbeing of smaller outer diameter than the other, the smaller outerdiameter spout being received in the air tube-equipped passage of saidstopper, the larger outer diameter spout being received in the otherpassage of said stopper, the smaller diameter spout being equipped withresilient means in sealing en gagement with said stopper.

2. In combination, a parenteral solution container equipped with aresilient stopper, said stopper having a pair of passages thereinadapted to communicate the interior of said container with the exteriorof saidstopper, an air tube mounted in one of said passages andextending only inwardly of said container and to a point adjacent thebottom of said container, a vial containing a supplemental medicamentfor the container solution, a closure secured to said vial, said closurebeing equipped with a pair of spaced apart, outwardly extending tubularspouts disposed in generally parallel relation, one of said spouts beingof larger outer diameter than the other, the larger outer diameter spoutbeing in sealing engagement with the Walls of the passage of saidstopper other than the passage equipped with said air tube, the smallerdiameter spout being mounted in the air tube-equipped passage of saidstopper, and sealing means about said smaller diameter spout interposedbetween said spout and said stopper.

3. In combination with a parenteral solution container closed with aresilient stopper having a liquid outlet passage and an air inletpassage equipped with an air tube, a device for coupling engagement withsaid container comprising a medicament-containing vial and a closure forsaid vial, said closure having a pair of parallel, spacedapart,outwardly extending, tubular, puncturing spouts having passagesextending therethrough, said spouts being of unequal outside diameter,the outside diameter of the larger of said spouts being about equal insize to the inside diameter of said outlet passage and the outsidediameter of the smaller of said spouts being less than the insidediameter of said air tube, said smaller spout being equipped with anannular resilient sleeve extending along the length therefo but,terminating a spaced distance from the tip of said spout so that whensaid device is in coupling engagement with said parenteral solutioncontainer, the spout of smaller outside diameter extends into said airtube and the resilient annular sleeve cooperates with 2,612,163 NormanSept. 30, 1952 said stopper to provide a contamination preventing seal.2,689,564 Adams et a1 Sept. 21, 1954 2,704,544 Ryan Mar. 22, 1955References Cited in the file of this patent 2,863,451 Ban- Dec. 9, 1958UNITED STATES PATENTS 5 2,884,924 Shaw y 1959 1,526,595 Gillrnan Feb.17, 1925 FOREIGN PATENTS 2, Mlllford e a1 May 28, 1940 1,122,616 FranceMay 28, 1956 2,580,836 Rausch Jan. 1, 1952 971,839 France Apr. 16, 1950

